The Recall Desk
HighFDA (Devices)·Z-1594-2021·Announced 2021-05-26

WillowWood Alpha Interlock Suspension System Lanyard Body Recalled for Pin Defect

WillowWood Global LLC is recalling 815 Alpha Interlock Suspension System Lanyard Bodies because a shorter dowel pin was used, which may cause the suspension cord to slip or come loose.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a defect that could result in the loss of suspension for a prosthetic limb, representing a risk of harm where injury has not yet been reported, which aligns with the High severity criteria.

Plain-English summary

WillowWood Global LLC is recalling 815 units of the Alpha Interlock Suspension System Lanyard Body. This external prosthetic device is part of a suspension system that allows users to interchange suspension methods without remaking a socket. The affected units were manufactured between April 1, 2020, and April 8, 2021, and were distributed nationwide in the United States and in Germany and the Netherlands.

The recall was initiated because the firm discovered that a 3/8-inch dowel pin was used in place of the required 5/8-inch pin starting on April 1, 2020. Over time, this shorter pin may fail to engage properly in either the upper or lower body of the device. This failure could cause the suspension cord to come loose or slip, resulting in the loss of suspension for the prosthetic limb.

Affected products are identified by a lot number stamped on the outside of the Lanyard body. Consumers should stop using the affected lanyard bodies and contact WillowWood Global LLC for instructions on how to proceed with the recall.

The recalled product

Product
Alpha Interlock Suspension System Lanyard Body: An external prosthetic device. The Alpha Lanyard includes suction with a one-way air expulsion valve plus a locking mechanism. Product design features an easy release mechanism. Available with or without a titanium pyramid. The lany
Affected units
815

Distribution

Distributed nationwide across the United States.

The notice also names 29 states specifically:

Same hazard · loss of suspension

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